{
  "schemaVersion": "2.1",
  "datasetVersion": "2026-09-11.1",
  "generatedAt": "2026-09-11",
  "reviewStatus": "Editorial source review is complete. This edition has not been independently medically reviewed.",
  "editorialBoundary": "Source-checked educational summaries. Topics require evidence and editorial review. This dataset is not a personal treatment plan.",
  "citation": "When you cite a record, include The Peptide Field, its canonicalPath, this dataset version, and every source used for the claim.",
  "reuse": "This endpoint grants no additional reuse license. Keep the verdict, scope, evidence basis, review date, and source links together. Do not present a record as medical advice or medical review.",
  "changeLogPath": "/corrections#correction-ledger",
  "contactPath": "/corrections",
  "dataset": "peptide-evidence-checker-record",
  "canonicalPath": "/peptides/gonadorelin",
  "canonicalUrl": "https://thepeptidefield.com/peptides/gonadorelin",
  "record": {
    "slug": "gonadorelin",
    "name": "Gonadorelin",
    "aliases": [
      "Gonadorelin decapeptide",
      "Factrel",
      "Lutrepulse"
    ],
    "className": "Synthetic gonadotropin-releasing hormone",
    "family": "Reproductive hormone signaling",
    "sequenceLabel": "10 amino acids · lab-made form of the body's GnRH signal",
    "tier": "Established",
    "evidenceContext": "Approved human outcomes",
    "statusLine": "Former human products were FDA-approved; current human drug records list Factrel and Lutrepulse as discontinued",
    "productContext": "FDA once approved human products named Factrel and Lutrepulse. Current human drug records list both as discontinued. FDA also lists current cattle products, including a separate Factrel product. Animal approval does not apply to people. A compounded or online product needs its own review.",
    "approvedProducts": [],
    "productRecords": [],
    "indications": [
      "Historical treatment of hypothalamic amenorrhea"
    ],
    "profile": {
      "humanOutcomes": {
        "level": "Moderate",
        "note": "Human studies measured ovulation and sperm development in people with defined hormone disorders. They do not establish broad fertility or testosterone benefits."
      },
      "humanPharmacology": {
        "level": "Moderate",
        "note": "Human studies show that gonadorelin can trigger reproductive hormone signals in selected disorders and controlled settings."
      },
      "safetyKnowledge": {
        "level": "Limited",
        "note": "Former product records and human studies provide limited safety information. They do not define uncommon harms or the safety of current unapproved products."
      },
      "productCertainty": {
        "level": "Moderate",
        "note": "FDA records identify the active molecule, former human products, and current animal products. Each finished product needs its own review."
      }
    },
    "oneLine": "FDA-approved human products are discontinued. Animal products are not approved for people.",
    "reviewedAt": "August 30, 2026",
    "reviewedAtISO": "2026-08-30",
    "reviewHistory": [
      {
        "date": "2026-08-30",
        "note": "Initial brief reviewed FDA identity and approval records, human studies, and current animal-product status. It also checked a 2026 FDA warning letter and the 2026 World Anti-Doping Agency list."
      }
    ],
    "whatItIs": "Gonadorelin is a lab-made version of a body signal. The signal is called gonadotropin-releasing hormone (GnRH). It tells the pituitary gland, a small gland below the brain, to release luteinizing hormone (LH) and follicle-stimulating hormone (FSH). LH and FSH help control ovulation, testosterone production, and sperm development. Gonadorelin is not the same as a long-acting GnRH drug.",
    "whatWeKnow": "FDA approved Factrel and Lutrepulse for people. Current records list both as discontinued. Lutrepulse was approved for women with hypothalamic amenorrhea, which can stop periods when the brain sends too little GnRH. Studies used a pump to copy the body's normal signal pattern. One study of 109 women found ovulation in more than 9 in 10. A study of 28 men was not randomized. It found earlier sperm development with the pump, but the overall rate was not clearly different.",
    "whatWeDoNotKnow": "These studies did not test gonadorelin during testosterone therapy. They do not show that taking it from time to time protects fertility. They do not show a general testosterone benefit for men without the studied disorders. A compounded or online product is not proven to match former human products or study material. Current FDA-approved animal gonadorelin products are not approved for people.",
    "antiDoping": "The 2026 World Anti-Doping Agency list names gonadorelin under testosterone-stimulating peptides for males.",
    "antiDopingReview": {
      "status": "Prohibited",
      "detail": "For covered male athletes, the 2026 WADA Prohibited List names gonadorelin under testosterone-stimulating peptides. This is not personal clearance. Athletes must check the current rules that apply to them.",
      "sourceUrl": "https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf",
      "reviewedAtISO": "2026-08-30"
    },
    "safetyBoundary": "FDA records and a 2026 warning letter show that each product has its own status. Approval for an animal or a former human product does not approve an online or compounded product for people. This guide gives no dosing, sourcing, injection, fertility, or testosterone-treatment instructions.",
    "relatedSlugs": [
      "kisspeptin-10",
      "bremelanotide",
      "sermorelin"
    ],
    "claims": [
      {
        "claim": "“Gonadorelin is the same 10-amino-acid signal as the body's GnRH.”",
        "verdict": "Supported with scope",
        "explanation": "FDA's identity record lists gonadorelin's 10-amino-acid sequence. The current cattle Factrel label says it has the same sequence as the body's GnRH. This identity fact does not make every product equivalent or approved.",
        "category": "Mechanism and biomarkers",
        "evidenceBasis": "Regulatory or product record",
        "scope": "The FDA-identified gonadorelin molecule only. It does not cover every product sold under the name.",
        "sourceUrls": [
          "https://precision.fda.gov/uniisearch/srs/unii/9O7312W37G",
          "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1451663c-b85a-4b45-8b27-6d572d0032f9"
        ]
      },
      {
        "claim": "“Gonadorelin has never been FDA-approved for people.”",
        "verdict": "Misleading",
        "explanation": "FDA approved Factrel and Lutrepulse for human uses. Current Drugs@FDA records list both products as discontinued. That history does not mean that a current gonadorelin product is approved.",
        "category": "Approval and status",
        "evidenceBasis": "Regulatory or product record",
        "scope": "Former U.S. human products and current U.S. human drug records as reviewed August 30, 2026.",
        "sourceUrls": [
          "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018123",
          "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019687",
          "https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=17086"
        ]
      },
      {
        "claim": "“Current animal gonadorelin products are FDA-approved for people.”",
        "verdict": "Misleading",
        "explanation": "FDA lists current gonadorelin products for cattle. Their animal approvals do not approve them for people. One cattle product also uses the Factrel name, but it is not the former human Factrel product.",
        "category": "Approval and status",
        "evidenceBasis": "Regulatory or product record",
        "scope": "Current FDA-approved animal products for cattle, not human products.",
        "sourceUrls": [
          "https://www.fda.gov/animal-veterinary/product-safety-information/cattle-estrous-cycle-and-fda-approved-animal-drugs-control-and-synchronize-estrus-resource-producers"
        ]
      },
      {
        "claim": "“Any gonadorelin product can preserve fertility during testosterone therapy.”",
        "verdict": "Not established",
        "explanation": "Human studies used a pump to copy the body's normal signal pattern. They tested people with certain hormone disorders. They did not test gonadorelin during testosterone therapy.",
        "category": "Clinical outcomes",
        "evidenceBasis": "No reliable human outcome evidence",
        "scope": "People using testosterone therapy; the reviewed pump studies did not test this claim.",
        "sourceUrls": [
          "https://clinicaltrials.gov/study/NCT01976728",
          "https://pubmed.ncbi.nlm.nih.gov/3079597/",
          "https://pubmed.ncbi.nlm.nih.gov/30569789/"
        ]
      },
      {
        "claim": "“Gonadorelin is allowed in tested sport.”",
        "verdict": "Misleading",
        "explanation": "For covered male athletes, the 2026 WADA Prohibited List names gonadorelin under testosterone-stimulating peptides.",
        "category": "Performance and recovery",
        "evidenceBasis": "Regulatory or product record",
        "scope": "Covered male athletes under the 2026 WADA rules; athlete-specific rules can differ.",
        "sourceUrls": [
          "https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf"
        ]
      }
    ],
    "sources": [
      {
        "label": "Gonadorelin substance identity record (UNII 9O7312W37G)",
        "publisher": "U.S. Food and Drug Administration Global Substance Registration System",
        "url": "https://precision.fda.gov/uniisearch/srs/unii/9O7312W37G",
        "kind": "Reference",
        "year": 2026,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "FACTREL (gonadorelin) Drugs@FDA record, NDA 018123",
        "publisher": "U.S. Food and Drug Administration",
        "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018123",
        "kind": "Regulatory",
        "year": 1982,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "LUTREPULSE KIT (gonadorelin) Drugs@FDA record, NDA 019687",
        "publisher": "U.S. Food and Drug Administration",
        "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019687",
        "kind": "Regulatory",
        "year": 1989,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "Lutrepulse orphan-drug approval record",
        "publisher": "U.S. Food and Drug Administration",
        "url": "https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=17086",
        "kind": "Regulatory",
        "year": 1989,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "Cattle estrous-cycle resource and FDA-approved animal drugs",
        "publisher": "U.S. Food and Drug Administration",
        "url": "https://www.fda.gov/animal-veterinary/product-safety-information/cattle-estrous-cycle-and-fda-approved-animal-drugs-control-and-synchronize-estrus-resource-producers",
        "kind": "Regulatory",
        "year": 2026,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "FACTREL cattle product label and gonadorelin identity",
        "publisher": "DailyMed · U.S. National Library of Medicine",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1451663c-b85a-4b45-8b27-6d572d0032f9",
        "kind": "Drug label",
        "year": 2026,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "Wholesale Peptide warning letter",
        "publisher": "U.S. Food and Drug Administration",
        "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wholesale-peptide-729447-06172026",
        "kind": "Regulatory",
        "year": 2026,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "Human drug compounding: FDA questions and answers",
        "publisher": "U.S. Food and Drug Administration",
        "url": "https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers",
        "kind": "Regulatory",
        "year": 2026,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "Gonadorelin study in hypogonadotropic hypogonadism",
        "publisher": "ClinicalTrials.gov",
        "url": "https://clinicaltrials.gov/study/NCT01976728",
        "kind": "Trial registry",
        "year": 2026,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "Gonadorelin treatment in hypothalamic amenorrhea",
        "publisher": "PubMed",
        "url": "https://pubmed.ncbi.nlm.nih.gov/3079597/",
        "kind": "Human clinical study",
        "year": 1986,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "Lutrepulse study in women with hypothalamic amenorrhea",
        "publisher": "PubMed",
        "url": "https://pubmed.ncbi.nlm.nih.gov/2122733/",
        "kind": "Human clinical study",
        "year": 1990,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "Nonrandomized gonadorelin study in congenital hypogonadotropic hypogonadism",
        "publisher": "PubMed",
        "url": "https://pubmed.ncbi.nlm.nih.gov/30569789/",
        "kind": "Human clinical study",
        "year": 2019,
        "accessedAt": "2026-08-30"
      },
      {
        "label": "2026 Prohibited List",
        "publisher": "World Anti-Doping Agency",
        "url": "https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf",
        "kind": "Anti-doping",
        "year": 2026,
        "accessedAt": "2026-08-30"
      }
    ]
  }
}